Inferior Vena Cava Collapsibility and Distensibility Assessment in Critical Care.
NCT ID: NCT06516692
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
180 participants
INTERVENTIONAL
2024-08-01
2024-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Moreover this study will help in development of future guidelines for fluid resuscitation in critically ill patients.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. Within 24 hours 7 day and 28 day mortality
2. Change in Sequential Organ failure Assessment (ΔSOFA) score from baseline to 24 hours after fluid management.
3. Cumulative fluid balance at 6 hours of fluid management
4. Days on mechanical ventilation
5. Days in Intensive Care Unit (ICU)
6. Change in lactic acid levels in sepsis sub group
7. Change in Blood sugar Random (BSR) in Diabetic ketoacidosis (DKA) sub group
8. Change in Power of Hydrogen (PH) in septic and diabetic ketoacidosis sub group of participant
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Clinical Parameters guided assessment arm
Participants recruited to this arm will be assessed for their hydration status and further fluid management as per usual care of assessment through
* Capillary refill time
* Presence/absence of pulmonary rales.
* Jugular venous pressure assessment by clinical methods
* Presence / absence of pedal edema
No interventions assigned to this group
Inferior Vena Cava Collapsibility and Distensibility guided assessment arm
Participants recruited in this arm will be assessed through measurement of inferior vena cava diameter via subcostal window within 3 cm of its opening to right atrium through point of care ultrasound using a curvilinear or phased array probe.
For spontaneously breathing patients Inferior Vena Cava Collapsibility Index (IVC CI) will be calculated as:
\[(IVC diameter max-IVC diameter min)/IVC diameter max\]×100%
* IVC CI \> 50% = overt hypovolemia
* IVC CI \< 20% = no overt hypovolemia
* IVC CI of 20% to 50% will be goal
For mechanically ventilated patients Inferior Vena Cava Distensibility Index (IVC DI) will be calculated as:
\[(IVC diameter max-IVC diameter min)/IVC diameter min\]×100% IVC distensibility\>18% = hypovolemia IVC distensibility\<18% = no hypovolemia
Inferior Vena Cava Collapsibility/distensibility Index (IVC CI/DI) assessment
Assessment of hydration status in critically ill patient recruited to this arm will be intervened through an ultrasound guided calculation of collapsibility and distensibility index of Inferior Vena Cava. This method of intervention will be continued and repeated as needed throughout the stay of the participant in intensive care unit.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Inferior Vena Cava Collapsibility/distensibility Index (IVC CI/DI) assessment
Assessment of hydration status in critically ill patient recruited to this arm will be intervened through an ultrasound guided calculation of collapsibility and distensibility index of Inferior Vena Cava. This method of intervention will be continued and repeated as needed throughout the stay of the participant in intensive care unit.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Sepsis
* Diabetic ketoacidosis
* Acute kidney injury
* Acute gastroenteritis
Exclusion Criteria
* Known case of congestive cardiac failure
* Presence of marked ascites
* IVC could not be identified or diameter could not be measured
* Pregnant females
* Body Mass Index (BMI) \>30 Kg/meter2
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jinnah Postgraduate Medical Centre
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shamim Kausar, EDIC,FCPS
Role: PRINCIPAL_INVESTIGATOR
Jinnah Post Graduate and Medical Centre
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Jinnah Post graduate Medical Centre
Karachi, Sindh, Pakistan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kashani K, Omer T, Shaw AD. The Intensivist's Perspective of Shock, Volume Management, and Hemodynamic Monitoring. Clin J Am Soc Nephrol. 2022 May;17(5):706-716. doi: 10.2215/CJN.14191021. Epub 2022 Apr 4.
Basmaji J, Arntfield R, Desai K, Lau VI, Lewis K, Rochwerg B, Fiorini K, Honarmand K, Slessarev M, Leligdowicz A, Park B, Prager R, Wong MYS, Jones PM, Ball IM, Orozco N, Meade M, Thabane L, Guyatt G. The Impact of Point-of-Care Ultrasound-Guided Resuscitation on Clinical Outcomes in Patients With Shock: A Systematic Review and Meta-Analysis. Crit Care Med. 2024 Nov 1;52(11):1661-1673. doi: 10.1097/CCM.0000000000006399. Epub 2024 Sep 18.
Musikatavorn K, Plitawanon P, Lumlertgul S, Narajeenron K, Rojanasarntikul D, Tarapan T, Saoraya J. Randomized Controlled Trial of Ultrasound-guided Fluid Resuscitation of Sepsis-Induced Hypoperfusion and Septic Shock. West J Emerg Med. 2021 Feb 10;22(2):369-378. doi: 10.5811/westjem.2020.11.48571.
Spiliotaki E, Saranteas T, Moschovaki N, Panagouli K, Pistioli E, Kitsinelis V, Briasoulis P, Papadimos T. Inferior vena cava ultrasonography in the assessment of intravascular volume status and fluid responsiveness in the emergency department and intensive care unit: A critical analysis review. J Clin Ultrasound. 2022 Jun;50(5):733-744. doi: 10.1002/jcu.23194. Epub 2022 Mar 18.
Kaptein EM, Kaptein MJ. Inferior vena cava ultrasound and other techniques for assessment of intravascular and extravascular volume: an update. Clin Kidney J. 2023 Jun 29;16(11):1861-1877. doi: 10.1093/ckj/sfad156. eCollection 2023 Nov.
Related Links
Access external resources that provide additional context or updates about the study.
The Intensivist's Perspective of Shock, Volume Management, and Hemodynamic Monitoring
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NO.F.2-81/2023-GENL/64/JPMC
Identifier Type: -
Identifier Source: org_study_id